Z-2202-2020 Class II Terminated
FDA device recall Z-2202-2020 was initiated by Agfa N.V. on April 6, 2020 and is designated Class II. Reason for recall: Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible The recall status is terminated (terminated April 3, 2023). Affected quantity: 13 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2020
- Initiation Date
- April 6, 2020
- Termination Date
- April 3, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 units
Product Description
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for mammography applications
Reason for Recall
Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible
Distribution Pattern
US Nationwide distribution including in the sates of FL, IL, IN, LA, MA, MO, OH, SC, VA, WI.
Code Information
Serial Numbers: 0925, 0945, 0948, 0949, 1003, 1022, 1116, 1136, 1161, 1229, 1239, 1401, and 1404